PALACE 3: Efficacy and Safety Study of Apremilast to Treat Active Psoriatic Arthritis - Full Text View

Sponsor:	Celgene Corporation
Information provided by (Responsible Party):	Celgene Corporation
ClinicalTrials.gov Identifier:	NCT01212770

Purpose

The purpose of this study is to determine whether apremilast is safe and effective in the treatment of patients with psoriatic arthritis and a qualifying psoriasis lesion.

Apremilast is proposed to improve signs and symptoms of psoriatic arthritis (tender and swollen joints, pain, physical function) in treated patients.

Condition	Intervention	Phase
Psoriatic Arthritis	Drug: Apremilast Drug: Placebo	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Efficacy and Safety Study of Two Doses Of Apremilast (CC-10004) In Subjects With Active Psoriatic Arthritis And A Qualifying Psoriasis Lesion

Resource links provided by NLM:

Genetics Home Reference related topics: psoriatic arthritis

MedlinePlus related topics: Psoriasis

U.S. FDA Resources

Further study details as provided by Celgene Corporation:

Primary Outcome Measures:

The signs and symptoms of psoriatic arthritis (as measured by the PsA modified American College of Rheumatology criteria for 20% improvement [ACR 20]). [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The number and frequency of adverse events in each arm. [ Time Frame: Weeks 0 - 264 ] [ Designated as safety issue: Yes ]
Physical function (as measured by the Health Assessment Questionnaire Disability Index [HAQ-DI] and the physical function domain of the Short Form 36 [SF-36] questionnaire) [ Time Frame: Every 13 weeks up to Week 264 ] [ Designated as safety issue: No ]
Clinical disease activity (as measured by the Clinical Disease Activity Index) [ Time Frame: Every 13 weeks up to Week 264 ] [ Designated as safety issue: No ]
Fatigue (as measured by the Functional Assessment of Chronic Illness Therapy - Fatigue [FACIT-Fatigue] score) [ Time Frame: Every 13 weeks up to Week 264 ] [ Designated as safety issue: No ]
Signs and symptoms of PsA (as measured by ACR 50 and ACR 70) [ Time Frame: Every 13 weeks up to Week 264 ] [ Designated as safety issue: No ]
Health-related quality of life measures [ Time Frame: Every 13 weeks up to Week 264 ] [ Designated as safety issue: No ]

Estimated Enrollment:	495
Study Start Date:	September 2010
Estimated Study Completion Date:	November 2015
Estimated Primary Completion Date:	June 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Apremilast 20 mg twice daily, orally	Drug: Apremilast Apremilast 20 mg twice daily, orally Other Name: CC-10004
Experimental: Apremilast 30 mg twice daily, orally	Drug: Apremilast Apremilast 30 mg twice daily, orally Other Name: CC-10004
Placebo Comparator: Placebo	Drug: Placebo Placebo

Detailed Description:

Psoriatic arthritis (PsA) is an inflammatory arthritis that occurs in 6-39% of psoriasis patients. The immunopathogenesis of PsA, which mirrors but is not identical to that seen in psoriatic plaques, reflects a complex interaction among resident dendritic, fibroblastic and endothelial cells, and inflammatory cells attracted to the synovium by cytokines and chemokines. Apremilast (CC-10004) is a novel oral agent that modulates multiple inflammatory pathways through targeted phosphodiesterase type 4 (PDE4) enzyme inhibition. Therefore, apremilast has the potential to be effective in the treatment of PsA.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Males or females, aged ≥ 18 years at time of consent.
Have a diagnosis of PsA (by any criteria) of ≥ 6 months' duration.
Meet the CASPAR criteria for PsA at time of screening.
Must have been inadequately treated by disease-modifying antirheumatic drugs (DMARDs)
May not have axial involvement alone
Concurrent Tx allowed with methotrexate, leflunomide, or sulfasalazine,
Have ≥ 3 swollen AND ≥ 3 tender joints.
Males & Females must use contraception
Stable dose of NSAIDs, narcotics and low dose oral corticosteroids allowed.
Have at least one ≥2 cm psoriasis lesion

Exclusion Criteria:

Pregnant or breast feeding.
History of allergy to any component of the investigational product (IP).
Hepatitis B surface antigen and/or hepatitis C antibody positive at screening.
Therapeutic failure on > 3 agents for PsA or > 1 biologic TNF blocker

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01212770

Show 26 Study Locations

Sponsors and Collaborators

Celgene Corporation

Investigators

Study Director:

Randall Stevens, MD

Celgene Corporation

More Information

No publications provided

Responsible Party:	Celgene Corporation
ClinicalTrials.gov Identifier:	NCT01212770 History of Changes
Other Study ID Numbers:	CC-10004-PSA-004
Study First Received:	September 29, 2010
Last Updated:	January 31, 2012
Health Authority:	United States: Food and Drug Administration Canada: Health Canada

Keywords provided by Celgene Corporation:

Psoriatic Arthritis
Psoriasis
Arthritis
inflammation
skin condition

inflammatory cells
apremilast
CC-10004
phosphodiesterase type 4

Additional relevant MeSH terms:

Arthritis
Arthritis, Psoriatic
Joint Diseases
Musculoskeletal Diseases
Spondylarthropathies
Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Thalidomide

Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents

ClinicalTrials.gov processed this record on May 23, 2012